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oai:recercat.cat:11351/112852025-10-24T10:32:08Zcom_2072_378070com_2072_378040col_2072_378092

Bevacizumab, Irinotecan, or Topotecan Added to Temozolomide for Children With Relapsed and Refractory Neuroblastoma: Results of the ITCC-SIOPEN BEACON-Neuroblastoma Trial Weston, Rebekah Owens, Cormac Valteau-Couanet, Dominique Gambart, Marion Castel, Victoria Moreno, Lucas Institut Català de la Salut [Moreno L] Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Weston R] University of Birmingham, Birmingham, United Kingdom. [Owens C] Children’s Hospital Ireland, Dublin, Ireland. [Valteau-Couanet D] Institut Gustave Roussy, Paris, France. [Gambart M] Hôpital des Enfants, Bordeaux, France. [Castel V] Hospital Universitario La Fe, Valencia, Spain Vall d'Hebron Barcelona Hospital Campus Neuroblastoma - Tractament Quimioteràpia combinada DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Germ Cell and Embryonal::Neuroectodermal Tumors::Neoplasms, Neuroepithelial::Neuroectodermal Tumors, Primitive::Neuroectodermal Tumors, Primitive, Peripheral::Neuroblastoma Other subheadings::Other subheadings::Other subheadings::/drug therapy ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols Other subheadings::Other subheadings::/therapeutic use ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias de células germinales y embrionarias::tumores neuroectodérmicos::neoplasias neuroepiteliales::tumores neuroectodérmicos primitivos::tumores neuroectodérmicos primitivos periféricos::neuroblastoma Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada Otros calificadores::Otros calificadores::/uso terapéutico Temozolomide; Children; Relapsed and refractory neuroblastoma Temozolomida; Niños; Neuroblastoma recurrente y refractario Temozolomida; Nens; Neuroblastoma recurrent i refractari Purpose Outcomes for children with relapsed and refractory high-risk neuroblastoma (RR-HRNB) remain dismal. The BEACON Neuroblastoma trial (EudraCT 2012-000072-42) evaluated three backbone chemotherapy regimens and the addition of the antiangiogenic agent bevacizumab (B). Materials and Methods Patients age 1-21 years with RR-HRNB with adequate organ function and performance status were randomly assigned in a 3 × 2 factorial design to temozolomide (T), irinotecan-temozolomide (IT), or topotecan-temozolomide (TTo) with or without B. The primary end point was best overall response (complete or partial) rate (ORR) during the first six courses, by RECIST or International Neuroblastoma Response Criteria for patients with measurable or evaluable disease, respectively. Safety, progression-free survival (PFS), and overall survival (OS) time were secondary end points. Results One hundred sixty patients with RR-HRNB were included. For B random assignment (n = 160), the ORR was 26% (95% CI, 17 to 37) with B and 18% (95% CI, 10 to 28) without B (risk ratio [RR], 1.52 [95% CI, 0.83 to 2.77]; P = .17). Adjusted hazard ratio for PFS and OS were 0.89 (95% CI, 0.63 to 1.27) and 1.01 (95% CI, 0.70 to 1.45), respectively. For irinotecan ([I]; n = 121) and topotecan (n = 60) random assignments, RRs for ORR were 0.94 and 1.22, respectively. A potential interaction between I and B was identified. For patients in the bevacizumab-irinotecan-temozolomide (BIT) arm, the ORR was 23% (95% CI, 10 to 42), and the 1-year PFS estimate was 0.67 (95% CI, 0.47 to 0.80). Conclusion The addition of B met protocol-defined success criteria for ORR and appeared to improve PFS. Within this phase II trial, BIT showed signals of antitumor activity with acceptable tolerability. Future trials will confirm these results in the chemoimmunotherapy era. Supported by Cancer Research UK (grant CRUK/11/056) and Imagine for Margo. Funding for national coordinating centers was also received by K.N. from the Danish Childhood Cancer Foundation (grants no. 2015-13 and 2016-0318), the German Children's Cancer Foundation (DKS 2013.24), 111 des Arts, Enfance & cancer, Enfants Cancer Santé, Kom op tegen Kanker, Zoe for Life. L.M. was funded (2016-2018) through Juan Rodes Fellowship (JR15/00041) by Instituto de Salud Carlos III. M.O.L. and N.K. acknowledge support from the Cancer Research UK Cancer Imaging Center, the NIHR Clinical Research Facility and the NIHR Biomedical Research Center. 2024-04-05T07:26:07Z 2024-04-05T07:26:07Z 2024-04-01 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Moreno L, Weston R, Owens C, Valteau-Couanet D, Gambart M, Castel V, et al. Bevacizumab, Irinotecan, or Topotecan Added to Temozolomide for Children With Relapsed and Refractory Neuroblastoma: Results of the ITCC-SIOPEN BEACON-Neuroblastoma Trial. J Clin Oncol. 2024 Apr 1;42(10):1135–45. 1527-7755 https://hdl.handle.net/11351/11285 10.1200/JCO.23.00458 38190578 http://hdl.handle.net/11351/11285 eng Journal of Clinical Oncology;42(10) https://doi.org/10.1200/JCO.23.00458 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess application/pdf American Society of Clinical Oncology Scientia